NCT02807779: INVADER_MRI

Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging

Completed Phase 4 Results posted Last updated 17 July 2025

What this trial tests

Phase 4 trial testing Dexamethasone infusion in Peripheral Artery Disease in 33 participants. Completed in 31 October 2022.

Timeline

10 February 2016

Primary endpoint
31 October 2020

31 October 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	33
Start date	10 February 2016
Primary completion	31 October 2020
Estimated completion	31 October 2022
Sites	2 locations across United States

Drugs / interventions tested

• Dexamethasone infusion — full drug profile →
• Drug coated balloon
• Plain balloon angioplasty

Conditions studied

• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
• Vascular Disease — all drugs for Vascular Disease →
• Critical Limb Ischemia — all drugs for Critical Limb Ischemia →

Sponsor

University of California, San Francisco

Who can join

35 and older, any sex, with Peripheral Artery Disease or Vascular Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Percent Wall Volume (PWV) Primary · From Post-Operative Day One to 12 Months

The change in percent wall volume (PWV) of the treated segment between the postoperative and 12 month time points as measured by MRI

Group	Value	95% CI
Dexamethasone	12.3	± 11.6
Drug-Coated Balloon	3.9	± 4.3

Change in Wall Volume (WV) Without a Change in Total Vessel Volume (TVV) Secondary · From Post-Operative Day One to 12 Months

The change in wall volume (WV) without change in total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI

Group	Value	95% CI
Dexamethasone	28.7	± 78.5
Drug-Coated Balloon	4.5	± 66.6

Change in Perioperative Inflammatory Profile (MCP-1) Secondary · From Post-Operative Day One to 12 Months

The serum concentration of monocyte chemoattractant protein-1 (MCP-1) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the MCP-1 concentration (postprocedure day 1, 1 month and 12 months)

Group	Value	95% CI
Dexamethasone	27933	± 3267
Drug-Coated Balloon	277745	± 4000

Change in Perioperative Inflammatory Profile (CRP) Secondary · From Post-Operative Day One to 12 Months

The serum concentration of C-reactive protein (CRP) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the CRP concentration (postprocedure day 1, 1 month and 12 months).

Group	Value	95% CI
Dexamethasone	1721	± 1171
Drug-Coated Balloon	1863	± 1475

Change in Transfer Constant (Ktrans) Secondary · From 1 Month to 6 Months

The change in adventitial transfer constant (Ktrans) of the treated segment between the postoperative and 6 month time points as measured by dynamic contrast enhanced MRI

Group	Value	95% CI
Dexamethasone	-0.0002	± 0.003
Drug-Coated Balloon	-0.0067	± 0.006

Change in Lumen Volume (LV) Relative to Total Vessel Volume (TVV) Secondary · From Post-Operative Day One to 12 Months

The change in lumen volume (LV) relative to total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI

Group	Value	95% CI
Dexamethasone	-12.3	± 11.6
Drug-Coated Balloon	-3.88	± 4.28

Percentage of Subjects With Clinically Significant Restenosis That Undergo Reintervention of Greater Than or Equal to 75% of the Treated Segment Secondary · From Post-Operative Day One to 12 Months

Percentage of subjects with clinically significant restenosis that undergo reintervention of greater than or equal to 75% of the treated segment by the 12 month timepoint.

Group	Value	95% CI
Dexamethasone	4
Drug-Coated Balloon	4
Plain Balloon Angioplasty	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexamethasone

Serious: 7/10 (70%)

Deaths: 1/10

Drug-Coated Balloon

Serious: 7/9 (78%)

Deaths: 1/9

Plain Balloon Angioplasty

Serious: 1/1 (100%)

Deaths: 0/1

Serious adverse events (6 terms)

Reaction	System	Dexamethasone	Drug-Coated Balloon	Plain Balloon Angioplasty
Reintervention requiring hospitalization	Vascular disorders	—	—	—
Death	Cardiac disorders	—	—	—
COVID pneumonia requiring hospitalization	Respiratory, thoracic and mediastinal disorders	—	—	—
Acute heart failure requiring admission	Cardiac disorders	—	—	—
Arterial access site pseudoaneurysm requiring operation	Vascular disorders	—	—	—
Unstable angina requiring coronary revascularization	Cardiac disorders	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Dexamethasone	Drug-Coated Balloon	Plain Balloon Angioplasty
Pacemaker placement	Cardiac disorders	—	—	—
Urinary tract infection	Renal and urinary disorders	—	—	—

Most-reported serious reactions: Reintervention requiring hospitalization, Death, COVID pneumonia requiring hospitalization, Acute heart failure requiring admission, Arterial access site pseudoaneurysm requiring operation, Unstable angina requiring coronary revascularization.

Data from ClinicalTrials.gov NCT02807779 adverse events section.

Sponsor's own description

This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Quantitative measurement of atheroma burden: reproducibility in serial studies of atherosclerotic femoral arteries.
   Wang Y, Liu X, Haraldsson H, Zhu C, et al · · 2020 · PMID 32297164 · DOI 10.1007/s10334-020-00843-7